Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
Mainsail
A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone With or Without Lenalidomide in Subjects With Castrate-Resistant Prostate Cancer (CRPC)
2 other identifiers
interventional
1,059
20 countries
197
Brief Summary
The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer. The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Nov 2009
Typical duration for phase_3 prostate-cancer
197 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2009
CompletedFirst Posted
Study publicly available on registry
October 2, 2009
CompletedStudy Start
First participant enrolled
November 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2012
CompletedResults Posted
Study results publicly available
September 5, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2016
CompletedApril 4, 2018
March 1, 2018
2.2 years
October 1, 2009
June 27, 2013
March 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley.
From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months
Secondary Outcomes (6)
Progression-Free Survival (PFS)
From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months
Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria
From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months
Number of Participants With Treatment Emergent Adverse Events (AEs)
From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL
Percentage of Participants Who Received Post-Study Therapies
The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017
Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial
The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days
- +1 more secondary outcomes
Study Arms (2)
Docetaxel, Prednisone, Lenalidomide (DPL)
EXPERIMENTAL25 mg lenalidomide orally once each day on Days 1-14; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice daily on each day of the treatment cycle
Docetaxel and Prednisone (DP)
EXPERIMENTALOral placebo once each day on Days 1-14 of the treatment cycle; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice each day on each day of the treatment cycle
Interventions
25 mg lenalidomide orally once each day on Days 1-14
75 mg/m2 intravenous docetaxel on Day 1
5 mg prednisone orally twice daily on each day of the treatment cycle
Oral placebo once each day on Days 1-14 of the treatment cycle
Eligibility Criteria
You may qualify if:
- Must sign an Informed Consent Form (ICF)
- Males ≥ 18 years of age
- Able to adhere to the study visit schedule and requirements of the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Life expectancy of ≥ 12 weeks
- Willingness to participate in Patient-Reported Outcomes assessments
- Serum testosterone levels \< 50 ng/dL
- Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy
- Have documented disease progression while receiving or following hormonal therapy as determined by increasing Serum Prostate Specific Antigen (PSA) level, Radiological Progression, or ≥2 new bone lesions
- Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide
- Refrain from donating blood or semen as defined by protocol
You may not qualify if:
- A history of clinically significant disease that places subject at an unacceptable risk for study entry
- Prior Therapy with thalidomide, lenalidomide or pomalidomide
- Prior chemotherapy for prostate cancer
- Use of any other experimental drug or therapy within 28 days prior to randomization
- Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization
- Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization
- Surgery within 28 days prior to randomization
- Concurrent anti-androgen therapy
- Abnormal serum chemistry or hematology laboratory values
- Significant active cardiac disease within the previous 6 months:
- Thrombotic or thromboembolic events within the past 6 months:
- History of peripheral neuropathy of ≥grade 2
- History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- Paraplegia
- History of Central nervous system (CNS) or brain metastases
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (210)
Hematology Oncology Associates
Phoenix, Arizona, 85012, United States
Northern AZ Hematology and Oncology Assoc
Sedona, Arizona, 86336, United States
Arizona Oncology
Tucson, Arizona, 85710, United States
City of Hope Cancer Center
Duarte, California, 91010-3000, United States
Southwest Cancer Center - Escondido
Escondido, California, 92025, United States
Scripps Cancer Center - Clinical Research
La Jolla, California, 92037, United States
VA Long Beach Healthcare System
Long Beach, California, 90822, United States
The Angeles Clinc and Research Institute
Los Angeles, California, 90025, United States
University of Southern California
Los Angeles, California, 90033, United States
Prostate Oncology Specialists
Marina del Rey, California, 90292, United States
Stanford University Medical Center
Stanford, California, 94035-5821, United States
Rocky Mountain Cancer Centers-Colorado Springs Circle
Colorado Springs, Colorado, 80909, United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010, United States
Melbourne Internal Medicine Associates
Melbourne, Florida, 32901, United States
Advanced Medical Specialties
Miami, Florida, 33176, United States
Florida Cancer Institute - New Hope
New Port Richey, Florida, 34655, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Cancer Centers of Florida, P.A.- West Gore Street
Orlando, Florida, 32806, United States
South Florida Oncology - Hematology
Tamarac, Florida, 33321, United States
Palm Beach Cancer Institute, LLC
West Palm Beach, Florida, 33401, United States
Cancer Care and Hematology Specialists of Chicagoland
Niles, Illinois, 60714, United States
Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Indiana University Health
Indianapolis, Indiana, 46219, United States
Hematology and Oncology Specialist, LLC
Metairie, Louisiana, 70006, United States
Maryland Oncology Hematology PA
Columbia, Maryland, 21044, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, 55404, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Summit Medical Group Overlook Oncology Center
Berkeley Heights, New Jersey, 07922, United States
Hematology-Oncology Associates of NNJ, P
Morristown, New Jersey, 07960, United States
Hematology Oncology Associates of South Jersey
Mount Holly, New Jersey, 08060, United States
New York Oncology Hematology P.C.
Albany, New York, 12208, United States
Columbia Univ Medical Center
New York, New York, 10032, United States
Weill Cornell Medical College Dr. Feldman's Office
New York, New York, 10065, United States
New Bern Cancer Care
New Bern, North Carolina, 28562, United States
Cancer Centers of North Carolina
Raleigh, North Carolina, 27607, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
Northwest Cancer Specialists-Tualatin
Tualatin, Oregon, 97062, United States
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29210, United States
Cancer Center of the Carolinas
Greer, South Carolina, 29650, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Cookeville Regional Medical Center
Cookeville, Tennessee, 38501, United States
Sarah Cannon Research Institute UK
Nashville, Tennessee, 37203-1632, United States
Texas Oncology, P.A.-Amarillo
Amarillo, Texas, 79106, United States
Texas Oncology-Arlington South
Arlington, Texas, 76014, United States
Texas Oncology, PA
Austin, Texas, 78758, United States
Baylor Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology, P.A.-Fort Worth
Fort Worth, Texas, 76104, United States
Longview Cancer Center
Longview, Texas, 75601, United States
Allison Cancer Center
Midland, Texas, 79701, United States
Texas Oncology, P.A. - Paris
Paris, Texas, 75460, United States
Southlake Oncology
Southlake, Texas, 76092, United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, 75702, United States
Texas Oncology Deke Slayton Cancer Center
Webster, Texas, 77598, United States
Texas Oncology-Texoma Cancer Center
Wichita Falls, Texas, 76310, United States
Veterans Education and Research Association of Northern New England, Inc.
White River Junction, Vermont, 05009, United States
Cancer Outreach Associates
Abingdon, Virginia, 24211, United States
Fairfax Northern Virginia Hematology Oncology
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014, United States
Columbia Basin Hematology and Oncology
Kennewick, Washington, 99336, United States
VA Puget Sound HCS Seattle Division
Seattle, Washington, 98108-1532, United States
Evergreen Hematology and Oncology
Spokane, Washington, 99218, United States
Royal Adelaide Hospital
Adelaide, South Australia, SA 5000, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Flinders Medical Centre
Bedford Park, 5042, Australia
Chris O'Brien Lifehouse
Camperdown, NSW 2050, Australia
Sir Charles Gairdner Hospital
Nedlands, 6009, Australia
Port Macquarie Base Hospital
Port Macquarie, NSW 2444, Australia
Redcliffe Hospital
Redcliffe, QLD 4020, Australia
Royal North Shore Hospital
St Leonards, 2065, Australia
Newcastle Calvary Mater Hospital
Waratah, 2298, Australia
Westmead Hospital
Westmead, NSW 2145, Australia
Border Medical Oncology
Wodonga, 3690, Australia
The Queen Elizabeth Hospital
Woodville South, 5011, Australia
Princess Alexandra Hospital
Woolloongabba, QLD 4102, Australia
Medical University of Graz
Graz, 8036, Austria
Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Krankenhaus der Barmherzigen Brueder
Vienna, 1020, Austria
Medizinische Universitat Wien
Vienna, 1090, Austria
ZNA Middelheim
Antwerp, 2020, Belgium
Hopital Erasme
Brussels, 1070, Belgium
Edith Cavell Clinic
Brussels, 1180, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
UZ Leuven
Leuven, 3000, Belgium
AZ Nikolaas
Sint-Niklaas, 9100, Belgium
The Health Institute for Men CMX Research Inc
Toronto, Ontario, M1P 2T7, Canada
Les Urologues Specialises
Montreal, Quebec, H2X 1N8, Canada
Krajska zdravotni, a.s. Nemocnice Chomutov, o.z.
Chomutov, 430 12, Czechia
Fakultni nemocnice Motol
Prague, 150 06, Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La
Ústí nad Labem, 40113, Czechia
Arhus Universitets hospital
Aarhus C, 8000, Denmark
Rigshospitalet University Hospital
Copenhagen, 2100, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Odense Universitetshospital
Odense C, 5000, Denmark
CRLCC Paul Papin
Angers, 49933, France
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux, 33076, France
Centre Georges Francois Leclerc
Dijon, 21079, France
Clinique Victor Hugo
Le Mans, 72000, France
Centre Oscar Lambret
Lille, 59020, France
Centre Leon Berard
Lyon, 69373, France
Clinique de Valdegour
Nîmes, 30900, France
CHU de Poitiers
Poitiers, 86021, France
Centre Eugene Marquis
Rennes, 35042, France
Institut de Cancerologie de la Loire
Saint Priest En Jaroz, 42270, France
CRLCC Centre Rene Gauducheau
Saint-Herblain, 44805, France
Hopital Civil de Strasbourg
Strasbourg, 67091, France
CHRU Hopital Bretonneau
Tours, 37044, France
Institut Gustave Roussy
Villejuif, 94805, France
Vivantes Klinikum am Urban
Berlin, 10967, Germany
Medizinisches Zentrum Bonn-Friedensplatz
Bonn, 53111, Germany
Diakonissenkrankenhaus Dessau gGmbH
Dessau, 06846, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225, Germany
Krankenhaus Nordwest
Frankfurt a.M., 60488, Germany
Onkologische Praxis Freiburg
Freiburg im Breisgau, 79106, Germany
Universitatsklinikum Hamburg-Eppendorf / IVDP
Hamburg, 20246, Germany
IORC- Innovation Onkologie Research and Consulting GmbH
Hamburg, 22081, Germany
Praxis fuer Haematologie und Onkologie Koblenz
Koblenz, 56068, Germany
Vituro GmbH & Co KG
Leipzig, 4277, Germany
TU München - Klinikum rechts der Isar
München, 81675, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
University-Hospital Tübingen
Tübingen, 72076, Germany
Universitatsklinikum Ulm
Ulm, 89075, Germany
Alexandra General Hospital of Athens
Athens, 11528, Greece
Agioi Anargyroi Hospital
Athens, 14564, Greece
University Hospital of Larissa
Larissa, 41110, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 56429, Greece
Fovarosi Onkirmanyzat Peterfy S.Utcai Korhaz-Rend.Int es Baleseti Kozp.
Budapest, 1076, Hungary
Fovarosi Onkormanyzat Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, 1106, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526, Hungary
Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar
Pécs, 7623, Hungary
The Soroka University Medical Center
Beersheba, 84101, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Assaf Harofeh Medical Center
Ẕerifin, 70300, Israel
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124, Italy
Ordine Mauriziano
Candiolo, 10023, Italy
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, 23100, Italy
Ospedale Vito Fazzi
Lecce, 73100, Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
Meldola, 47014, Italy
Ospedale di Mirano
Mirano (VE), 30035, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Ospedale degli Infermi di Rimini
Rimini, 47900, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00149, Italy
Azienda Ospedaliero-Universitaria Santa Maria della Miserico
Udine, 70124, Italy
Hospital Angeles Lindavista
D.F, DF, 07760, Mexico
Consultorio de Especialidad en Urologia Privado
Durango, DGO, 34000, Mexico
Hospital Fatima
Sinaloa, SIN, 81200, Mexico
Consultorio Privado- Dr Jose Arturo Rodriguez Rivera
Zapopan, JAL, 45040, Mexico
VU University Medical Center VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Ziekenhuis Rijnstate
Arhem, 6800 TA, Netherlands
Amphia Ziekenhuis Molengracht
Breda, 4818 CK, Netherlands
Gemini Ziekenhuis
Den Helder, 1782 GZ, Netherlands
Albert Schweitzer Ziekenhuis Amstelwijck
Dordrecht, 3317 NM, Netherlands
Catharina Ziekenhuis
Eindhoven, 5632 EJ, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD, Netherlands
Leids Universitair Medisch Centrum
Leiden, 2333 ZA, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, 6229 HX, Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3435 CM, Netherlands
Erasmus Medical Center
Rotterdam, 3015 GD, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
HagaZiekenhuis
The Hague, 2545 CH, Netherlands
Twee Steden Ziekenhuis Tilburg
Tilburg, 5042 AD, Netherlands
VieCuri Medisch Centrum Venlo
Venlo, 5912 BL, Netherlands
Isala Klinieken
Zwolle, 8025 AB, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Regionalny Osrodek Onkologiczny WSS im. M. Kopernika
Lodz, 93-509, Poland
ZOZ MSWiA z Warminsko- Mazurskim Centrum Onkologii
Olsztyn, 10-228, Poland
NZOZ Olsztynski Osr. Onkologiczny Kopernik Sp.z o.o
Olsztyn, 10-513, Poland
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
Rybnik, 44-200, Poland
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
Wroclaw, 50-981, Poland
Moscow Oncology Clinical Dispensary 1
Moscow, 105005, Russia
Medical Radiology Research Centre RAMS
Obninsk, 249036, Russia
State Institution of Heath Omsk Regional Oncology Dispensary
Omsk, 644013, Russia
Russian Scientific Center for Radiology and Surgical Technol, St. Petersburg
Pesochny Vlg Saint Petersburg, 197758, Russia
NSHI Dorozhnaya Clinical Hospital of OAO Russian Railways
Rostov-on-Don, 344011, Russia
Oncology Dispensary 2 of Krasnodar Region
Sochi, 354057, Russia
Yaroslavl Regional Clinical Oncology Hospital
Yaroslavl, 150054, Russia
Groote Schuur Hospital
Cape Town, W Cape, 7925, South Africa
The Oncology Centre Durban
Durban, KZ-Natal, 4091, South Africa
Westridge Medical Centre
Durban, KZ-Natal, 4091, South Africa
Netcare Oncology and Interventional Centre
Goodwood, W Cape, 7460, South Africa
Dr. H. Malan
Polokwane, 699, South Africa
Pretoria Urology Hospital
Pretoria, 0083, South Africa
Hospital del Mar
Barcelona, 08003, Spain
Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO
Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Arnau de Vilanova
Lleida, 25198, Spain
Hospital 12 de Octobre
Madrid, 28041, Spain
HCU Virgen de la Victoria
Málaga, 29010, Spain
Clinica Universitaria de Navarra
Pamplona, 31008, Spain
Hospital Mutua de Terrassa
Terrassa (Barcelona), 08221, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Lanssjukhuset Ryhov
Jönköping, 55185, Sweden
Norrlands Universitetssjukhus
Umeå, 90185, Sweden
Centrallasarettet Vasteras
Västerås, 721 89, Sweden
Clatterbridge Centre for Oncology NHS Trust
Bebington, Wirral, CH63 4JY, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Royal Surrey County Hospital
Guildford, GU2 7XX, United Kingdom
Guy's and St Thomas' Hospital - London
London, SE1 9RT, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Christie NHS Trust Hospital
Manchester, M20 4BX, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
Scunthorpe, DN15 7BH, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Related Publications (3)
Vogelzang NJ, Fizazi K, Burke JM, De Wit R, Bellmunt J, Hutson TE, Crane E, Berry WR, Doner K, Hainsworth JD, Wiechno PJ, Liu K, Waldman MF, Gandhi A, Barton D, Jungnelius U, Fandi A, Sternberg CN, Petrylak DP. Circulating Tumor Cells in a Phase 3 Study of Docetaxel and Prednisone with or without Lenalidomide in Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2017 Feb;71(2):168-171. doi: 10.1016/j.eururo.2016.07.051. Epub 2016 Aug 10.
PMID: 27522164BACKGROUNDPetrylak DP, Vogelzang NJ, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, de Olza MO, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, Van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, de Wit R, Fizazi K. Docetaxel and prednisone with or without lenalidomide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (MAINSAIL): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2015 Apr;16(4):417-25. doi: 10.1016/S1470-2045(15)70025-2. Epub 2015 Mar 3.
PMID: 25743937RESULTde Morree ES, Vogelzang NJ, Petrylak DP, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, Ochoa de Olza M, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, Li JS, de Wit R. Association of Survival Benefit With Docetaxel in Prostate Cancer and Total Number of Cycles Administered: A Post Hoc Analysis of the Mainsail Study. JAMA Oncol. 2017 Jan 1;3(1):68-75. doi: 10.1001/jamaoncol.2016.3000.
PMID: 27560549RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The independent DMC concluded that it was unlikely the trial would achieve its primary endpoint of improved overall survival. The sponsor agreed and the experimental lenalidomide/placebo treatment arm of the study was discontinued.
Results Point of Contact
- Title
- Senior Manager , Clinical Trials Disclosure
- Organization
- Celgene Corporation
Study Officials
- STUDY DIRECTOR
Debora Barton, MD
Celgene Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2009
First Posted
October 2, 2009
Study Start
November 11, 2009
Primary Completion
January 13, 2012
Study Completion
November 28, 2016
Last Updated
April 4, 2018
Results First Posted
September 5, 2013
Record last verified: 2018-03